Summary Company Announcement Date: April 16, 2026 FDA Publish Date: April 20, 2026 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Risk of the syringe rotating adapter unwinding during use, which may result in a loose connection and/or full disconnection between the syringes and manifold, potentially causing biohazard exposure, blood loss, infection, or…

This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. This recall was classified on October 1, 2025.  …

This recall involves updating instructions for using devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions. This recall was classified…

This recall involves correcting devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.   Affected Product The FDA is aware that Philips has issued…

CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.   Affected Product The FDA is aware that American Contract Systems has issued a letter to affected customers recommending certain angiographic…

CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.  Affected Product The FDA is aware that Medical Action Industries has issued a letter to affected customers recommending certain angiographic syringes…

This recall involves correcting devices where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.   Affected Product The FDA is aware that Stryker has issued letters to affected customers recommending certain TMJ Unilateral…

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.   Affected Product The FDA is aware that Merit Medical has issued a letter to affected customers…

Affected Product The FDA is aware that Cook Medical has issued a letter to affected customers recommending certain sizing catheters be removed from where they are used or sold. The affected devices are: Centimeter Sizing Catheters Aurous Centimeter Sizing Catheters Beacon Tip Centimeter Sizing Catheters The full list of affected product lots can be found here.   What…

CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.   The FDA is aware that AVID Medical has issued an Urgent Medical Device Recall Notification to affected customers recommending certain…